The convergence of GxP for GMP Auditing to an integrated system is just around the corner. 2019-2020 are shaping up to present the quandary of what many have thought but any have not done to plan for what’s coming around Med Device quality management and compliance. Come listen regarding the predictive model for the convergence of a new regulated horizon for medical device. Learn to be prepared by setting plans in motion for an approach that will be only 2 years in the making. Medical Device as a QMS is now under the certification to ISO 13485:2016 for compliance in CANADA by Q3 2019. MDSAP will be the applicable auditing arrangement by qualified registrars. FDA has announced plans for the transition of QSR with QMS elements by 2020. Are you reading between the lines! Be prepared. Know what your path should consider!
- Learn what the drivers are in the convergence model
- Learn how to instigate an aggressive plan to meet the upcoming transition
- Digest the conceptual shifts in thinking by regulatory bodies
- Learn to adopt the “new” process/risk based approach to internal auditing
- Learn about a new conceptual model for training planning and execution
- Understand the adaption of supplier/contractors in the convergence model
- Quality Departments
- Regulatory Affairs Departments
- Research and Development Departments
- Auditing Management
- Engineering Departments
- QA/QC CAPA Admins
- CMO’s
- Operations Management
- Management Teams
- Problem Solvers
- Decision Makers and Planners
- Everyone that are required to participate in QSR/QMS planning as a regulatory requirement
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